This invention relates to peripherally inserted central and/or midline catheters lines and, more specifically, to a dividable catheter line introducer device that is fitted with a simple, very reliable and effective needle guard. The needle guard positively prevents hazardous needle sticks when the introducer needle has been retracted from the introducer catheter. After removal of the needle guard, a peripherally inserted central and/or midline catheter line is inserted through the catheter introducer into the patient, and the introducer catheter is divided into two halves that are removable from the line and patient.
Intravenous catheters for the infusion of fluids into the veins of a patient are typically one of two general types. One type is the xe2x80x9cthrough-the-needlexe2x80x9d catheter wherein the catheter is threaded through the needle and into the vein of a patient. In the through-the-needle type catheter, the needle is not withdrawn from the patient upon placement of the catheter. The second type of catheter is the xe2x80x9cover-the-needlexe2x80x9d type. Upon insertion of the introducer catheter into a patient, the insertion needle is withdrawn leaving the catheter in the body.
Needle guards are known in the art, but are generally limited for use with short peripheral catheters. The introducer needle is mounted in the needle guard so that when the needle is removed from the catheter it is received into the needle guard. It is also known in the art to use positive-lock needle guards that positively lock the needle in the guard.
Short peripheral catheters are distinguishable from peripherally inserted central catheter (xe2x80x9cPICCxe2x80x9d) lines in that PICC lines are inserted into the vascular system of the patient whereas short peripheral catheters are inserted into a vein of the patient. Not surprisingly, these different applications require different catheter structures and correspondingly different restrictions to the use of a needle guard on the introducer catheter.
In the use of a PICC line, a flexible catheter is introduced into the vascular system of a patient and subsequently manipulated to move the catheter through the vascular system of a patient to a desired location. Because the catheter must be moved upwardly through the vascular system, the catheter must be formed from a soft, biocompatible, pliable, and flexible material which is capable of winding through and extending through substantial lengths of the vascular system. It is not unusual for such catheters to extend from two to thirty inches or more through the vascular system of a patient. The insertion of the PICC line must also occur without causing trauma to the vascular system.
Because of the need to insert the PICC line catheter such long distances into the vascular system of a patient, the prior art devices tended to use through-the-needle catheter systems. In these through-the-needle catheter systems, after venous insertion, the needle or cannula is retained within the patient and the desired length of catheter is inserted through the cannula and into the vein of the patient. As will be apparent to those of ordinary skill in the art, in such applications, blood leakage is commonplace which exposes administrating personnel to substantial health risks, such as that associated with the AIDS virus, hepatitis, and other infectious diseases.
In view of these concerns, over-the-needle catheter systems have been recently introduced specifically adapted for PICC line applications. The use of over-the-needle catheter systems has made the use of needle guard that much more difficult.
In one prior art device, the insertion of a limited length (i.e., finite length) of catheter into a patient""s vein is facilitated while permitting the needle to be withdrawn after the initial insertion via a stylet extending through the catheter and then stowed within a protective sheath to prevent accidental puncture and/or exposure. However, this prior art device is limited to the length of the catheter provided, necessitating the correct initial selection of catheter length. Further, this device has a relatively complex construction, is relatively costly to fabricate, increases the patient""s cost, and is relatively complicated to use, requiring a significant amount of training and manipulative skill.
The short peripheral catheter, on the other hand, poses fewer barriers to the incorporation of a needle guard on the introducer catheter. The short peripheral catheter, like the syringe, employs only a needle stick to introduce a catheter that remains external to the patient""s body. Therefore, the problems encountered where a catheter is inserted into the vascular system of a patient do not arise with the use of a short peripheral catheter. As such, the short peripheral catheter introducer relatively easily allows incorporation of a needle guard.
Today, PICC line introducers typically are xe2x80x9cover-the-needlexe2x80x9d catheters. Typically, the introducer needle used with PICC lines is not used with a needle guard assembly. The introducer needle is therefore exposed when removed from the body. The exposed introducer needle, after withdrawal from the catheter, exposes healthcare workers to the possibility of accidental needle sticks and all the associated risks of exposure to bloodborne pathogens during the subsequent handling and disposal process.
In an effort to overcome these problems, several devices have been disclosed in the prior art that attempt to provide some means of closing off, blocking, containing or otherwise preventing the needle tip in a syringe, catheter, or similar device from being exposed after withdrawal from a patient.
One such prior art system is disclosed in U.S. Pat. No. 5,000,740 to Ducharme et al. A catheter device is described with a safety needle guard that covers and protects the needle after use of the device. The device includes a semi-tubular needle housing containing a flash chamber with a hollow needle extending from the distal end of the flash chamber. A tubular needle guard concentrically fits and slides within the needle housing. The needle guard has a longitudinal slot through which the mounting base of the flash chamber passes as the guard slides within the housing. The top of the semi-tubular housing is open so that a user may access the top of the tubular needle guard with a finger to urge the needle guard to an extended position from the distal end of the housing and in a surrounding position about the needle. As the needle guard attains its fully extended position about the needle, it locks in place in the needle housing.
Another prior art system is disclosed in U.S. Pat. No. 5,000,736 to Kaufhold, Jr. et al. A medicinal syringe including a tubular plunger from which air has been evacuated and a seal member releasably attached on the distal end of the plunger. Upon application of a predetermined longitudinal axial force to the seal member, the attachment between the seal member and the plunger will rupture, releasing the seal member for movement within the plunger. The seal member when released will be forced by the differential pressure between the vacuum and the ambient air into the interior of the tubular plunger. The plunger is slidably disposed in a tubular barrel. A needle is disposed in a hub releasably attached within the distal end of the barrel. Upon application of a predetermined longitudinal axial force to the hub, the attachment between the hub and the barrel will rupture, releasing the hub for movement within the barrel. The hub when released will be forced by the pressure differential, along with the distal plunger seal member, into the interior of the tubular plunger, carrying the needle with it. The attachment between the hub and barrel is adapted to rupture prior to that between the seal member and plunger. Once drawn into the tubular plunger, the needle and hub will remain there indefinitely, thus eliminating accidental puncturing by the needle of a person in the vicinity of the syringe.
Bonaldo, U.S. Pat. No. 4,917,669, discloses a catheter inserter has an inserter housing with a flat base and a cannula housing disposed within the inserter housing with a cannula extending generally parallel to the inserter housing longitudinal axis. Stop means are disposed at each end of the inserter housing, locking means on the cannula housing selectively engage the stop means to lock the cannula housing in a first disposition in which the cannula extends outwardly from the inserter housing and in a second disposition in which the cannula is retracted within said inserter housing. The cannula housing has a passage in fluid communication with the cannula which, together with means on the inserter housing and cannula housing, permit the external viewing of flood passing into the fluid passage from the cannula.
Lasaitis et al, U.S. Pat. No. 5,102,394, discloses a catheter assembly for intravenous therapy includes a protective shield to protect health care personnel from inadvertent injury. The protective shield can be selectively positioned on the assembly to permit manipulation of a needle member of the assembly so that the needle member can be withdrawn from an associated tubular catheter member. After the needle member is withdrawn, it is received within the shield member, and is substantially enclosed therein so that the needle member can disposed of without injury to personnel.
Sircom, U.S. Pat. No. 5,458,658, discloses an automatic needle guard for intravenous catheter assemblies, which stores the insertion needle between the needle base and catheter hub, which attaches by positive engagement to the catheter hub, remains attached while the needle is withdrawn through the needle guard following insertion of the catheter, locks immovably to the needle shaft when the needle tip enters the body of the needle guard, then releases from the catheter hub, allowing the needle guard to be withdrawn along with the needle for safe disposal.
Another prior art system is disclosed in U.S. Pat. No. 5,279,591 to Simon. A protector guard housing is disclosed for a catheter type needle apparatus to prevent accidental needle puncture. The guard housing is initially positioned between the hub of the catheter and the handle of the needle which slidably extends through the catheter in a known manner. A detent mechanism initially retains the forward end of the guard to the catheter hub while needle supports within the guard permits the needle to axially move relative to the guard. When the needle is withdrawn from the catheter after site puncture, a resilient closure wall formed in the protector closes the protector""s forward end while the needle""s cutting end is simultaneously wedged into contact with friction retention material in the protector. The needle""s cutting end is thus encapsulated within the protector when the detent mechanism releases the protector from the catheter.
Purdy et al., U.S. Pat. No. 5,215,528, discloses an assembly for introducing a catheter into a blood vessel is provided. The assembly includes a needle hub having a needle secured thereto. The needle includes an elongate shaft having a bevelled tip. A portion of the needle shaft adjacent to the tip has a relatively large outside diameter. The shaft diameter of this portion exceeds the diameter, of the shaft portion adjoining the tip and the diameter of the shaft portion extending between the enlarged shaft portion and the needle hub. A catheter is mounted over the shaft of the needle, and includes an inner surface which bears against the enlarged shaft portion. A substantially leak-proof seal is thereby provided between the catheter and the needle shaft. A needle tip cover is slidably mounted to the needle shaft and is engageable with the enlarged portion of the shaft to prevent its removal therefrom. The catheter is releasably mounted to the needle tip cover.
Steinman, U.S. Pat. No. 5,409,461, discloses a winged catheter introducer is disclosed. The catheter introducer has a catheter, a robe attached to the catheter and a winged intermediate member between the catheter and the robe. Within the catheter and the robe is a needle with a stylet attached to it. The stylet is attached to a hub which facilitates the pulling of the needle out of the catheter and through the robe. Attached to the robe is an adapter with a septum attached to it. The needle is provided with an opening extending from the needle wall to the needle lumen. A shielding device is provided which is attached to the adapter. The shielding device includes a needle container which is designed to trap the needle. A needle shield is provided inside the needle container. The needle is provided with an area of enlarged diameter. This area of enlarged diameter interacts with the needle shield when the needle is withdrawn from the catheter and robe and into the needle container. The needle shield is provided with an orifice through which the needle and stylet can fit but through which the area of enlarged diameter cannot pass. When the needle is withdrawn from the catheter and tube and into the needle container, it is trapped by the needle shield. The needle shield is also provided with a transverse wall which snaps over the point of the needle.
Haining, U.S. Pat. No. 5,176,650, discloses to protect against accidental needle prick a catheter and insertion device are provided wherein the needle is retractable within the device after insertion of the catheter. The device comprises a hollow barrel or tube of semi-rigid plastic material into which the needle can be retracted after use. The insertion needle is mounted on a carrier with the sharp end oriented toward an open insertion end of the barrel with the catheter snugly fit about the needle. A sliding tab is mounted to the carrier by an outwardly biased flexible member and extends through a longitudinal slot in the barrel. Near either end of the slot V notches are provided in the internal wall of the barrel to engage locking hubs on the sliding tab to releasably lock the carrier in either the exposed or retracted position. A flat catheter locking surface is provided at the insertion of the barrel with a reverse slope to allow the catheter flange to slide onto the flat surface and allow easy retraction of the needle without disturbing the inserted catheter.
Lemieux, U.S. Pat. No. 4,952,207, discloses an I.V. catheter is described, including a catheter and hub assembly and a needle and hub assembly. A needle guard, including a tubular distal portion and a split proximal flange, is located about the needle at the distal end of the needle hub. The needle includes a slot near the needle tip. As the needle assembly is withdrawn from the catheter, the needle guard slides along the needle until the split flange engages the needle slot, which locks the tubular distal portion of the guard over the needle tip.
Rossetti, U.S. Pat. No. 5,201,713, discloses one-way intravenous catheter assembly provided with a tubular needle guard slidable with respect to the needle housing, so as to completely cover the needle both before and after use, said needle housing comprising a substantially cylindrical central body with a flash chamber and a tapered front portion, to which the catheter needle is attached, and a peripheral finger gripping element, connected to the central body but extending around the tubular needle guard, the connection being provided by a connecting element which is slidable in a longitudinal slot of the tubular needle guard, the catheter assembly being further provided with a catheter tube or cannula mounted around the needle and provided with a hub for engagement with said tapered front portion of the needle housing.
Chang et al., U.S. Pat. No. 5,419,766, discloses a new catheter stick protector is described having a metal flap clip which snaps down into place to prevent return of the needle through the protector device once withdrawn. The device is small and received over the needle to provide an interface between the needle hub and the hub of a catheter like product. A sleeve of hydrophobic or fluid impermeable material is provided and attached at one end to the needle hub and at a second end to the tip protector. The length of the material is selected to hold the tip protector in a position just extending beyond the tip of the needle of a catheter inserter.
The present invention overcomes many of the deficiencies of the prior art by providing a introducer catheter and needle guard assembly combination that can be used for inserting a PICC line into a patient. The introducer catheter includes a first and second end and defines a fluid passageway between the first and second ends. The catheter includes a tube portion that terminates at the first end and is adapted for insertion into a body. The catheter also includes a connector hub for connecting to the needle guard assembly.
The needle guard assembly includes a housing and a slidable needle hub mounted within the housing and holding the needle. The needle hub and needle are slidable to an extended position wherein the needle extends through the passageway in the catheter and the sharp end or tip of the needle projects beyond the first end of the catheter. The needle hub and needle are also slidable to a retracted position wherein the needle is completely contained in the housing. The needle guard assembly may also include means for locking the needle hub and needle in the retracted position to prevent escape of the needle from the housing, or in the extended position to prevent movement of the needle within the body of a patient.
The catheter includes a connector for securing the catheter to the needle guard assembly. In an embodiment, the connector comprises a hub having a male luer for connection to a female luer on the needle guard assembly. While the use of male and female luer connectors is preferred, it will be understood that other suitable connectors could be used for connecting the catheter to the needle guard assembly.
In an embodiment, the catheter includes means for dividing or splitting the catheter into two halves. The catheter is divided or split in order to remove the catheter from a PICC line or other similar line inserted into the body of a patient. The dividing means preferably include at least one score line along the longitudinal length of the tube portion. In a preferred embodiment, the tube portion includes a pair of diametrically opposed score lines running along the longitudinal length of the tube to facilitate easy dividing and tearing of the tube portion catheter into two halves.
The dividing means also preferably include a means for dividing the connector hub into two portions. In a preferred embodiment, the connector hub is comprised of two halves that are held together by being fitted within a corresponding connector on the needle guard assembly. In an embodiment, the two halves of the hub connector include cooperating detents or a gasket to seat the connector hub. In an alternate embodiment, the connector hub is a one-piece assembly, and the connector hub includes a pair of diametrically opposed score lines to facilitate tearing of the connector hub into two halves. The connector hub and tube portion may be integral components or the tube portion may be swaged into a separate hub connector.
In an embodiment, the catheter includes a pair of arms that can be gripped by the user to facilitate dividing or splitting of the catheter. The arms includes flanges that are adhesively or otherwise secured to the two halves of the tube portion. The arms are bendable back and forth with respect to the tube portion to facilitate tearing of the tube portion into two halves. The arms are further adhesively or otherwise secured to the two halves of the connector hub of the catheter for facilitating separation of the connector hub into its respective two halves. The arms are preferably secured to the tube portion on opposite sides of the score line or score lines that run along the longitudinal length of the tube portion and secured to the connector hub on opposite sides of the separation line between the two halves of connector hub.
The present invention further includes a method for introducing a PICC line or other similar line into a body of a patient. In a preferred embodiment, the introducer catheter and needle guard assembly are preferably sold and provided in a connected one-piece assembly. Alternatively, the catheter and needle guard assembly can be sold unconnected and the user would first connect the needle guard assembly to the introducer catheter. In either embodiment, the needle hub and needle are then slid to the extended position so that the sharp end of the needle projects outwardly from the tube portion of the introducer catheter. The needle is then inserted into the body of a patient and the tube portion of the introducer catheter follows the needle into the body. After placement of the introducer catheter, the needle hub and needle are retracted so that the needle is completely contained in the housing. The needle guard can then be safely disconnected from the introducer catheter without danger of exposure to the sharp end of the needle. The needle guard assembly can then be discarded. The PICC line, or other similar line, is then introduced to the open end of the connector hub of the introducer catheter. The PICC line is slide through the tube portion of the introducer catheter and into a desired position within the body of a patient. After final placement of the PICC line, the healthcare worker can bend the arms on the introducer catheter back and forth with respect to the tube portion in order to initiate and facilitate tearing along the score lines on the tube portion to tear the introducer catheter into two halves. The two halves of the connector hub also easily separate because the needle guard assembly has been disconnected from the connector hub, or the connector hub can be torn into two halves if it is a single-piece assembly having a score line to facilitate tearing. Once the catheter is completely separated into two halves, the entire catheter can be easily removed from the PICC line and the body of the patient. The two halves of the introducer catheter can then be discarded, and just the PICC line, or other similar line, is left inserted in proper position into the body of the patient.